eligibility_summary
Inclusion: adults 18–75 with advanced/metastatic NSCLC, ECOG 0–1, candidate for active therapy, sexually active in the past 30 days, written consent. Exclusion: endocrine disorders (except controlled hypothyroidism on levothyroxine ≥2 yrs), chronic liver disease, hormonal therapy (e.g., ADT), conditions limiting sexual activity/PROs (e.g., leptomeningeal disease, unstable cord compression, vertebral fractures, gonadal mets, uncontrolled neuro/surgical issues), unresolved chemo gonadotoxicity, meds affecting sexuality, major psych/substance disorders.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Observational study assessing endocrine toxicity and sexual dysfunction in men with advanced NSCLC on standard therapies. Drugs/mechanisms (type): Alectinib, Brigatinib, Lorlatinib—ALK (lorlatinib also ROS1) tyrosine kinase inhibitors (small-molecule TKIs), Osimertinib—mutant-selective, irreversible EGFR TKI, Sotorasib—covalent KRAS G12C inhibitor, Dabrafenib—BRAF V600 inhibitor, Trametinib—MEK1/2 inhibitor, Selpercatinib—RET TKI, Pembrolizumab, Cemiplimab, Nivolumab—anti–PD-1 immune checkpoint inhibitors (monoclonal antibodies), Carboplatin—DNA crosslinking platinum, Pemetrexed—antifolate antimetabolite (TS/DHFR/GARFT), Paclitaxel—microtubule-stabilizing taxane. Targeted cells/pathways: tumor ALK/ROS1, EGFR, KRAS G12C, BRAF/MEK, RET signaling, PD-1 on T cells (enhancing antitumor immunity), DNA synthesis and mitosis in rapidly dividing cells. The study explores impacts on HPG axis/gonadal function.